NB686080-21-00149 Brand Name Justifcation Redacted.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

BRAND NAME JUSTIFICATION

NB686080-21-00149

1. Identification of the agency and the contracting activity.

Department of Commerce National Institute of Standard and Technology (NIST) Office of Acquisition and Agreements Management Acquisition Management Division 325 Broadway, MS 141 Boulder, CO 80305

2. Nature and/or description of the action being approved.

Request for approval to move forward with this procurement as a Brand Name Only. The action to be approved is of a new contract contemplated as a Firm-Fixed-Price (FFP) contract for a Hyperfine Swoop portable, low-field Magnetic Resonance Imaging (MRI) system in support of the NIST quantitative MRI program for the Physical Measurement Laboratory (PML). The procedures in Federal Acquisition Regulation (FAR) subpart 13 are to be used for this acquisition.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The Magnetic Imaging Group in the Applied Physics Division requires a Food and Drug Administration (FDA)-approved, portable, low-field MRI system to develop quantitative MRI standards and measurements at a low magnetic field. We define a low field to be greater than 10 mT and less than 500 mT. Also required are training to use the device from the manufacturer and maintenance and software upgrades from the manufacturer. The Magnetic Imaging Group at NIST requires the system for imaging of reference objects (phantoms) and persons to understand system variability and conduct research with human subjects. The system must be FDA-approved and available for sale in the US and must operate at low magnetic field strength. Additionally, to adapt to changing laboratory conditions and expected construction projects on the NIST Boulder campus, a portable system is determined to be most useful.

Low-field MRI is an emerging market with at least five companies offering new products in this area. In NIST’s role to support the US industry, we require the Hyperfine system to best support US companies in this emerging market and US adopters of this novel technology (e.g., hospital systems, small radiology practices). Without a Hyperfine system, we will be unable to provide quantitative MRI standardization guidance to adopters of this new technology. Additionally, we have a NIST-funded project that specifies using an FDA-approved low-field device; not procuring the Hyperfine system would result in an inability to meet project deliverables.

Questions for potential vendors:

Please detail any components of the system or software that are not FDA-approved.

If the Picture archiving and communication system (PACS) is operated locally, does it need to be a dedicated server, or could it be a computer used for multiple purposes?

What method is used to encrypt any data stored on the MRI system itself?

If the MRI system is connected to a PACS system, are images stored on the MRI system? If yes, for how long?

If a device is used to operate the MRI system, are images stored on that device en route to the

PACS system?

NB686080-21-00149 Brand Name JOFOC 2 of 3

When system updates are performed remotely (if possible), what data, if any, is sent to the vendor? Please provide examples of these files.

The vendor shall provide one Hyperfine Swoop MRI system. The performance period is 12 weeks after receipt of the award for a base period of 12 months and four, 12 months options periods with an estimated award value of

4. An identification of the statutory authority permitting other than full and open competition.

The statutory authority for this action is 11.105(a)(1) in accordance with 41 USC. 1901.

5. A demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited.

Only the Hyperfine Brand Name products will satisfy NIST's needs. This is a Brand Name only justification for Hyperfine equipment and service. The Brand Name justification is based on the following: Hyperfine is the only source capable of providing the required technical support services.

Without the required Hyperfine hardware equipment and service, specific experiments for the quantitative MRI project are not possible. At present, the Magnetic Imaging Group has funding to complete measurements of low-field MRI systems on both reference objects and human subject participants. To obtain Institutional Review Board (IRB)-approval for these experiments in a timely fashion, an FDA-approved device with safety and training support directly from the manufacturer is required. The required support is available only through Hyperfine.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Federal Acquisition Regulation (FAR) subpart 5.2, and, if not, which exception under 5.202 applies.

Sources Sought notice NB686080-21-00149 was posted to beta.SAM.gov on December 31, 2020, with NAICS 334516 – Analytical Laboratory Instrument Manufacturing, seeking sources who could provide a Portable, low-field magnetic resonance imaging (MRI) system. Responses were due on January 6, 2021.

A revised Sources Sought notice NB686080-21-00149 was posted to beta.SAM.gov on December 31, 2020, updating the NAICS to 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing, seeking sources who could provide a Portable, low-field magnetic resonance imaging (MRI) system.

Responses were due on January 6, 2021. Two viable responses were received.

7. A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable.

The Government's anticipated cost will be fair and reasonable because the Contracting Officer expects to receive adequate price competition from two or more responsible small business Offerors through the solicitation among resellers. Also, the Government will compare the prices against the Independent Government Estimate and other related purchases.

8. A description of the market research conducted (see part 10) and the results or a statement of the reason market research was not conducted.

Five companies were contacted through various methods, such as searching the internet and contacting vendors. The market research concluded that only hardware manufactured by Hyperfine to include training and subscriptions service provided by Hyperfine could meet the SOW specifications. Market research indicated that one reseller is negotiating with Hyperfine to provide the specific equipment required; another reseller was identified through another source although not contacted. It is not clear that the reseller can provide the training and subscription services that are required.